Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-15

Study Completion Date

2026-10-15

Brief Summary

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The REMAP study aims to follow a cohort of 400 patients in around ten sleep centers in France and to collect clinical routine data. The objectives of this study are to investigate the effects of one-year management of OSA by CPAP or MAD on sleep architecture defined by objective macro and micro sleep architecture parameters using a sleep test device. sleep connected at home, to assess the quality of sleep and the quality of life reported by patients. The study will also allow us to define predictive factors for improving sleep quality during OSA treatment.

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Detailed Description

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Conditions

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OSA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient treated with CPAP

CPAP

Intervention Type DEVICE

Fixed-pressure CPAP device for the treatment of sleep apnea with optional humidification and heated circuit. This device is a Class II device. It has a remote monitoring function allowing service providers to track the use of the device.

Patient treated with MAD

MAD

Intervention Type DEVICE

mandibular device orthosis made to measure from the dental impressions of patients, made by the specialist in the masticatory apparatus for the treatment of sleep apnea.

Interventions

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CPAP

Fixed-pressure CPAP device for the treatment of sleep apnea with optional humidification and heated circuit. This device is a Class II device. It has a remote monitoring function allowing service providers to track the use of the device.

Intervention Type DEVICE

MAD

mandibular device orthosis made to measure from the dental impressions of patients, made by the specialist in the masticatory apparatus for the treatment of sleep apnea.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient already included in the SunSAS study (No. ID/RCB: 2021-A01827-34) or Patient who has undergone polygraphy or polysomnography eligible for treatment with CPAP or MAD in the context of OSA.
* Patient with a sleep test performed with the Sunrise device
* Men or Women from 18 to 80 years old
* Patient with OSAS eligible for CPAP or MAD therapy
* Affiliated patient or beneficiary of a social security scheme
* Signed informed consent

Exclusion Criteria

* Patient previously treated for OSAS by CPAP or MAD during the last five years
* Patient with COPD or other respiratory diseases.
* Patient with contraindications to PPC or MAD therapy
* Patient with unstable heart disease or New York Heart Association class III or IV heart failure
* Patient unable to complete the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No